Label: PITAVASTATIN CALCIUM- pitavastatin calcium tablet, film coated

  • NDC Code(s): 72603-479-01, 72603-480-01
  • Packager: NorthStar RxLLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 27, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PITAVASTATIN TABLETS safely and effectively. See full prescribing information for PITAVASTATIN TABLETS. PITAVASTATIN tablets, for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:  • Adults with primary hyperlipidemia. • Adults and pediatric ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosage and Administration Information - • Take pitavastatin tablets orally once daily with or without food at the same time each day. • For patients that require a ...
  • 3 DOSAGE FORMS AND STRENGTHS
    1 mg: White to off-white, round, bevel edged biconvex film coated tablets debossed with ‘H1’ on one side and ‘P’ on other side. 2 mg: White to off-white, round, bevel edged biconvex film ...
  • 4 CONTRAINDICATIONS
    Pitavastatin tablets are contraindicated in the following conditions:  • Concomitant use of cyclosporine - [see - Drug Interactions (7)] . • Acute liver failure or ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myopathy and Rhabdomyolysis - Pitavastatin may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed in other sections of the labeling:  • Myopathy and Rhabdomyolysis - [see - Warnings and Precautions (5.1)]   ...
  • 7 DRUG INTERACTIONS
    Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with pitavastatin and instructions for preventing or managing drug ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary  - Discontinue pitavastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pitavastatin ...
  • 10 OVERDOSAGE
    No specific treatment for pitavastatin overdose is known. Contact Poison Control (1-800-222-1222) for latest recommendations. Hemodialysis is unlikely to be of benefit due to high protein ...
  • 11 DESCRIPTION
    Pitavastatin tablets for oral use are HMG-CoA reductase inhibitors.  The chemical name for pitavastatin calcium is monocalcium bis [(3 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 92-week carcinogenicity study in mice given pitavastatin, at the maximum tolerated dose of 75 mg/kg/day with systemic maximum ...
  • 14 CLINICAL STUDIES
    Primary Hyperlipidemia in Adults - Study with Atorvastatin (Study 301)  Pitavastatin was compared with atorvastatin calcium tablets (referred to as atorvastatin) in a randomized ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Pitavastatin tablets 2 mg are white to off-white, round, bevel edged biconvex film coated tablets debossed with ‘H2’ on one side and ‘P’ on other side. They are supplied as follows ...
  • 17 PATIENT COUNSELING INFORMATION
    Myopathy and Rhabdomyolysis  - Advise patients that pitavastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain types of medication and ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Pitavastatin Tablets 2 mg 90s Container Label - Pitavastatin Tablets 4 mg 90s Container Label
  • INGREDIENTS AND APPEARANCE
    Product Information